On September 23, 2013, HHS announced that it has entered into a contract with the Institute of Medicine to begin work to develop “clinical diagnostic criteria” for ME/CFS.

But there’s more.

On the same day, 35 of the leading researchers and clinicians in the field of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) have written an open letter to Health and Human Services Secretary Kathleen Sebelius to announce that they have reached a consensus on adopting the Canadian Consensus Criteria (CCC) as the research and clinical case definition for ME/CFS. They called for HHS to follow their lead by using the CCC as the sole case definition for ME/CFS in all of HHS’s activities related to the disease and strongly urged HHS to abandon its plans to reach out to groups like the Institute of Medicine to develop clinical diagnostic criteria.

Acknowledging that the case definition will be refined as science advances, the authors unambiguously endorsed the Canadian Consensus Criteria as the baseline criteria, stating:

“The expert biomedical community will continue to refine and update the case definition as scientific knowledge advances, for example, this may include consideration of the 2011 ME International Consensus Criteria … As leading researchers and clinicians in the field, however, we are in agreement that there is sufficient evidence and experience to adopt the CCC now for research and clinical purposes, and that failure to do so will significantly impede research and harm patient care.”

Just as directly, the authors stated their strong opposition to the IOM initiative, stating:

“We strongly urge [HHS] to abandon efforts to reach out to groups such as the Institute of Medicine (IOM) that lack the needed expertise to develop “clinical diagnostic criteria” for ME/CFS. Since the expert ME/CFS scientific and medical community has developed and adopted a case definition for research and clinical purposes, this effort is unnecessary and would waste scarce taxpayer funds that would be much better directed toward funding research on this disease. Worse, this effort threatens to move ME/CFS science backward by engaging non-experts in the development of a case definition for a complex disease about which they are not knowledgeable.”

Wow! Could our experts have spoken any more clearly, loudly and collectively?

More than any other issue, HHS’ decades long failure to adopt a definition that actually reflects our disease has confounded research and forestalled drug development. It has caused doctors to dismiss their patients’ illness or attribute it to depression. It has bred the widespread stigma and misunderstanding that ME/CFS patients face every day. By its actions, HHS has abandoned ME patients to lives of terrible debility and suffering with no treatments, no care and no hope that anything will ever change. In the face of such suffering, some patients have chosen suicide.

Compounding its mistakes, HHS unilaterally entered into a contract with the Institute of Medicine (IOM) to develop clinical diagnostic criteria and has repeatedly stated its intent to use non-experts to define our disease. We need only look to the Gulf War Illness experience with IOM and chronic multisymptom illness to know that this would be disastrous.

But today, thanks to our experts, the time for pretending ME/CFS doesn’t exist is OVER! The time for burying this devastating disease inside of an illegitimate collection of unexplained fatiguing illnesses is OVER! To quote advocate Tom Hennessey, NO MAS!

HHS can no longer claim that there is a lack of consensus amongst disease experts. As with every other disease, it is time for HHS to follow the lead of our disease experts and adopt the CCC for research and clinical purposes. In particular, HHS must now stop wasting taxpayer dollars on misguided efforts that, in the words of the letter authors, “threaten to move ME/CFS science backwards.”

For patients who have suffered through years of studies into ‘false illness beliefs” and maladaptive coping styles, this is finally a way out of the morass, an escape route from all those wasted years. As the authors stated, adopting the CCC will “jump start progress and lead to much more rapid advancement in research and care for ME/CFS patients.” It gives hope that our disease will be treated as the terrible disease that it is and that progress will now come quickly. It gives hope that we will soon rise up from our beds!

This letter is remarkable and historic for the ME/CFS community.

But what does this letter mean in terms of the IOM contract that HHS has just signed? Typically, like most contracts, government contracts have mechanisms built into them to allow the contract to be cancelled when the contract no longer makes sense.

Now that the ME/CFS experts have spoken, the path forward is clear. It does not make sense to waste money and time redefining the disease when the experts have now agreed upon the immediate adoption of the CCC.

We need to send two strong messages to HHS. First, HHS needs to immediately adopt the CCC as the sole definition for ME/CFS as the experts have called for. Second, HHS needs to cancel the IOM contract, which is completely unnecessary, wasteful and a step backwards scientifically.

We need to forcefully engage our congressional leaders on this issue. Further information along with the actions to take with congressional leaders will be provided as soon as possible.

The Sept 23, 2013 open letter from ME/CFS researchers and clinicians to Secretary Sebelius can be found here – http://bit.ly/15npS9B

We remember Nancy Lee saying “Nothing about us without us”…

In Chronic Fatigue Syndrome Advisory Committee (CFSAC) discussions Designated Federal Official (DFO)Nancy C. Lee, M.D. has used the phrase “Nothing about us without us” implying that stakeholders should be involved in all things regarding ME/CFS.

But (on Sept 12th) HHS says:

“We continue to work on a contract with the Institute of Medicine (IOM) to develop recommendations for clinical diagnostic criteria. When the contract is finalized, we will provide additional information via the CFSAC listserv and website. This topic will be included as an agenda item for the November webinar.”

Yet CFSAC members, ME experts and ME stakeholders have been shut out of the HHS/IOM contract development and process.

Sooooo, how exactly is that “Nothing about us without us”? (Just to be clear — the question is in jest.)

Because the reality is that HHS is moving ahead on the IOM contract unilaterally and with total disregard for the overwhelming opposition from the ME community. HHS is undermining the work of ME experts while patients are suffering and dying.”

I strongly urge the Department to abandon its plan to contract with the Institute of Medicine (IOM) to define its own clinical diagnostic criteria for myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS).

Researchers and clinicians with years of experience in studying and treating this disease have already created peer-reviewed case definitions – the 2003 Canadian Consensus Criteria (CCC) and the 2011 ME International Consensus Criteria (ME-ICC), which used the CCC as its baseline. These definitions are supported by clinical guidelines for medical practitioners, guidelines also created by experts. These definitions are well regarded by patients, ME doctors, and ME researchers. The CCC has been used both clinically and in research for years.

But rather than adopt these expertly defined disease criteria and the associated medical guidelines, HHS has promoted its own overly broad view of ME that does not require the hallmark symptoms of ME. HHS has questioned these hallmark criteria and misrepresented our disease in its medical education. HHS has even unilaterally reclassified “CFS” to be a subtype of chronic fatigue, in complete opposition to the standards set by the World Health Organization and all other countries that classify this disease as a neurological disease.

Now, HHS is intent on defining its own new criteria for ME using the IOM, an organization whose only effort to define a disease was harshly criticized by Gulf War Illness Advocates for redefining the disease too broadly and for using non-experts to define the disease. HHS has repeatedly stated their intent to use non-experts to define ME. This is a very serious concern for patients who face widespread disbelief every day from the general medical and research community. Adding to these concerns, the description of ME/CFS in the January 2013 IOM report on Gulf War treatments failed to accurately represent ME and listed CBT and GET as treatments, treatments that our experts have said can be harmful.

HHS is progressing the IOM contract unilaterally and with disregard for the overwhelming opposition from the ME community. HHS is undermining the work of our experts while patients are suffering and dying. HHS must stop wasting precious time and dollars. HHS must stop wasting our precious lives.

I strongly urge HHS to abandon its plans to contract with the IOM to define clinical diagnostic criteria for ME/CFS. It is time for HHS to adopt a definition that our experts have created and use that definition to drive an aggressive campaign of fully funded research and to reeducate the medical community.

During the development of the proposed DHHS/IOM project, it seems that DHHS did not involve CFSAC members or let them know what was going on. We do not know if ex-officios were involved at all – because the project was progressed without the knowledge of, or input from the ME community. When advocates contacted some of our clinical and research experts it turns out that they had no idea about the proposed project until the advocates brought it to their attention.

For some time now, DHHS has wanted to use non-experts in the definition process – CFSAC DFO (designated federal officer) Nancy Lee has pushed really hard on that on a number of occasions. Non-experts? – to define a disease that many non-experts know little if anything about and that many don’t believe is real? Somehow that does not inspire warm and fuzzy feelings of comfort and confidence.

In May 2013, at the CFSAC meeting, Beth Unger of the CDC indicated that she is not certain post-exertional exacerbation (PEM) should be a required symptom of ME. At least one other person on the CFSAC has indicated that they think PEM is optional and should not be a required in a definition of ME. Yet, ME experts agree that PEM is a cornerstone, a hallmark of this illness. Is a definition that does not include illness hallmarks one that can accurately describe the illness?

DHHS appears to have changed its position on consensus definitions and who they believe to be the most appropriate groups for developing them. The minutes from the CFSAC Oct 2012 meeting indicate that Secretary Sebelius believed that definitions need to come from the medical community:

“In general, the Federal Government isn’t in the position of telling doctors a case definition. I think a recommendation from CFSAC that the Secretary should tell people to use “X” definition will go nowhere because that’s not what we do. This is a clinical decision that has to come from the clinical community. . .

I’ve been in two or three meetings with the Secretary since I’ve been here. One of them was around this: the idea of a case definition, the need for one, and in addition, the need for a different name for the disease. She basically said that this has to be coming from the medical community. CFS Advisory Committee Minutes, October 4, 2012, p. 37, 38.”

All of this seems a long way off from the CFSAC recommendation of Oct 2012:

“CFSAC recommends that you will promptly convene (by 12/31/12 or as soon as possible thereafter) at least one stakeholders’ (Myalgic Encephalomyelitis (ME)/Chronic Fatigue Syndrome (CFS)experts, patients, advocates) workshop in consultation with CFSAC members to reach a consensus for a case definition useful for research, diagnosis and treatment of ME/CFS beginning with the 2003 Canadian Consensus Definition for discussion purposes.” http://www.hhs.gov/advcomcfs/recommendations/10032012.html

DHHS still has not given a response about the allegations made at the May meeting.

And with this secretive DHHS/IOM proposal, DHHS has shattered the little remaining trust many people had in them.

The draft strategic plan for DHHS F2014-2018 was released earlier this week and one sentence in it reads:

Has DHHS ensured the effectiveness of the CFSAC program by implementing CFSAC recommendations?

Has DHHS demonstrated its accountability to the CFSAC and the ME community by their actions?

Do DHHS actions demonstrate that they care about what we have to say, that they respect and value our input and that of ME experts?

After all, according to the CFSAC charter, the CFSAC is supposed to be made up of experts in ME – experts selected by and appointed by DHHS. (“Of the eleven members, seven shall be biomedical research scientists with demonstrated expertise in biomedical research applicable to CFS; four shall be individuals with expertise in health care delivery, private health care services or insurers, or voluntary organizations concerned with the problems of individuals with CFS.” http://www.hhs.gov/advcomcfs/charter/index.html ) —

To what extent does DHHS engage with the CFSAC and demonstrate that they respect and value the input provided by the CFSAC?

Can we continue to believe that their intentions for us are honorable and truly in our interest?

Or does it seem that nothing that has been said about ME, to DHHS for the past decades has yielded significant positive results for us?

A slightly different sample letter (feel free to adapt) is posted below.

Each of these letters reflects the cancellation of the proposed solicitation and urges DHHS to stop attempting to redefine ME.

Dear Secretary Sebelius,

I understand that HHS has canceled the IOM contract but will “continue to explore mechanisms to accomplish this work” While I appreciate that the Department has responded to the public by cancelling this contract, I object to the Department continuing to explore other mechanisms to define criteria for myalgic encephalomyelitis/chronic fatigue syndrome”. The experts have already defined this disease.

I am a member of the ME community and have witnessed firsthand the devastation of this disease. I purposely use the term “ME” to distinguish the disease that has affected me from the overly broad “CFS”.

Two peer-reviewed consensus case definitions, developed by experts in this disease, already exist – the 2003 Canadian Consensus Criteria (CCC) and the 2011 ME International Consensus Criteria (ME-ICC), which used the CCC as its baseline. The CCC has been used both clinically and in research. Both are accompanied by clinical guidelines for medical practitioners, and are well regarded by patients, ME doctors, and ME researchers. Given that expertly defined and accepted consensus clinical criteria already exist, anything other than officially adopting one of these definitions wastes scarce taxpayer dollars and is unnecessary.

HHS has inexplicably refused to accept the CCC or the ME-ICC and even questions the hallmark symptoms of ME. Instead, it has promoted an overly broad view of the disease called “CFS”, which does not require the hallmark symptoms. This has confounded ME with depression, deconditioning and non-specific chronic fatigue, has severely impeded appropriate research, and is the direct cause of the medical skepticism and inappropriate or harmful treatment recommendations to which patients are subjected.

While you no longer appear to be seeking a contract with the IOM to develop a consensus definition, the fact that this effort was progressed in secret, apparently for many months and without consultation with key ME stakeholders is extremely disconcerting. In addition, the timing of the announcement before a holiday weekend and the short response time indicates that HHS was not looking for input from the ME experts and ME community.

I do not see the need for anything but the official adoption of one of the existing, expert consensus criteria.